APPLICATION
ANDA078166
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-27
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CIPROFLOXACIN EXTENDED RELEASEDiscontinued
CIPROFLOXACIN 212.6MG, CIPROFLOXACIN HYDROCHLORIDE EQ 287.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
CIPROFLOXACIN EXTENDED RELEASEDiscontinued
CIPROFLOXACIN 425.2MG, CIPROFLOXACIN HYDROCHLORIDE EQ 574.9MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-09-20Labeling · Supplement 17 · standardAP
2024-09-12Labeling · Supplement 16 · standardAP
2019-05-03Labeling · Supplement 14 · standardAP
2019-04-26Labeling · Supplement 12 · standardAP
2018-10-18Labeling · Supplement 13 · standardAP
2016-07-26Labeling · Supplement 11 · standardAP
2016-07-18Labeling · Supplement 9 · standardAP
2016-07-18Labeling · Supplement 10 · standardAP
2013-08-14Labeling · Supplement 8 · standardAP
2012-11-14Labeling · Supplement 6 · standardAP
2010-03-17Labeling · Supplement 2AP
2009-06-19Labeling · Supplement 1AP
2007-11-27OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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